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Integration of Exercise Into Cancer Care: A Shared Care Model

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ClinicalTrials.gov Identifier: NCT03661242
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
Gundersen Health System
Information provided by (Responsible Party):
Landspitali University Hospital

Study Description
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Brief Summary:
Multiple organizations endorse physical activity for cancer patients; however the structure for oncologist prescribed exercise has not been clearly established. A focus group study previously conducted at Gundersen Health System identified a patient preference for integrated care surrounding physical activity. Thus, the focus of this study will be to investigate the effects of a shared care model on the physical activity levels of cancer patients. The shared care model will consist of regularly scheduled visits with the patient's oncologist in combination with a clinical exercise physiologist. The clinical exercise physiologist (CEP) will assist in developing an individual activity plan with the patient. The Investigators predict the shared care model patients will have a higher level of activity, functional capacity and quality of life.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Physical activity Not Applicable

Detailed Description:

Numerous organizations, including the American Cancer Society, American College of Sports Medicine, National Comprehensive Cancer Network, U.S. Department of Health and Human Resources and Oncology Nursing Society have endorsed physical activity for cancer patients both when undergoing treatment and during the survivorship phase of care. Previous studies have consistently found physical activity to be associated with improved quality of life. However, current guidelines for oncologist prescribed exercise are vague and not supported with adequate training and/or education.

A focus group study previously conducted at Gundersen Health System found that oncologists' reluctance to discuss physical activity with patients is rooted in their own ability to safely guide patients through an exercise program. Cancer patients have also reported uncertainty about what types, frequency and intensity of physical activity in which to engage and it has been suggested that a referral process is critical to inclusion of exercise prescription into cancer care. Investigator´s previous study, along with others, have found that patients want advice and support about exercise while enduring the physiological and psychological side effects of treatment, yet do not want to be referred elsewhere. Thus, it seems there is a dilemma of translating safe and sustainable physical activity into standard cancer care.

A potential solution to this perceived shortcoming is a shared care model of cancer care delivery, wherein an oncologist is partnered with a certified exercise physiologist or physical therapist to develop an individualized, holistic care plan for each patient. In addition to providing the patient with standard of care cancer therapy as prescribed by the oncologist, the shared care model will also provide the patient with a customized physical activity plan developed by the exercise physiologist in consultation with the oncology staff and after meeting with the patient during a regularly scheduled oncology office visit. In this study the Investigators propose to investigate the impact of shared care visits with an oncologist and exercise physiologist on quality of life and functional capacity during cancer treatment. This model provides patients with easy access to the advice and support they desire without the need for additional referrals and travel, while ensuring a comprehensive assessment of risks and the development of safe progression of activities. Plan is to recruit total of 120 patients.

Statistical analysis will utilized a mix of descriptive and comparative statistics. Descriptive metrics will include means and associated 95% confidence intervals, medians and frequency counts. Comparison of demographic and clinical factors between study groups will utilize the Chi-square test for categorical data, the Wilcoxon rank sum test or Kruskal-Wallis test for ordinal discrete or non-normally distributed continuous data and Student's t-test or ANOVA for normally distributed continuous data. Evaluation of the primary outcome will utilize repeated measures ANOVA to compare the change overall quality of life over the study period, assessed via the FACT-G instrument, between the study groups. A p-value < 0.05 will be used as the threshold for statistical significance for all tests.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The design is a quasi-experimental prospective double- cohort study in which a lead-in group will be enrolled and receive standard of care and an intervention group will be enrolled one year after the last lead-in patient is accrued. The intervention group will receive shared care with an oncologist and an exercise physiologist trained in providing activity and exercise guidelines to the cancer patient population.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Integration of Exercise Into Cancer Care: A Shared Care Model
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard of care
No intervention
Active Comparator: Shared care
Clinic visit with Clincal Exercise Physiologist or physical therapist who does assessment and prescripes individulized physical activity plan
 Behavioral: Physical activity
Patients in shared care arm has regular combined visits with Oncologist and Clincal Exercise Physiologist (CEP). Individual physical activity plan developed by CEP for patients in shared care arm.


Outcome Measures
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Primary Outcome Measures :
  1. Functional Assessment of Cancer Therapy - General (FACT-G QOL) measurement. [ Time Frame: Month 0 (first visit), month 1, month 3, month 6, month 9, month 12 ]
    Change in score of FACT-G QOL measurement.


Secondary Outcome Measures :
  1. 6-minute walk test [ Time Frame: Month 0 (first visit), month 1, month 3, month 6, month 9, month 12 ]
    Change in 6-minute walk test

  2. International Physical Activity Questionnaire (IPAQ) score [ Time Frame: Month 0 (first visit), month 1, month 3, month 6, month 9, month 12 ]
    Change in International Physical Activity Questionnaire (IPAQ) score

  3. Patient Health Questionnaire 9 (PHQ-9) score [ Time Frame: Month 0 (first visit), month 1, month 3, month 6, month 9, month 12 ]
    Change in Patient Health Questionnaire (PHQ) score


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older
  • Pathologic confirmed cancer diagnosis
  • Patients receiving adjuvant treatment (chemotherapy and/or radiation) with curative intent
  • ECOG performance status 0-2

Exclusion Criteria:

  • Unable to ambulate
  • Comorbidity contraindicated PA as per treating physician
  • Non-English speaker
  • Receiving maintenance chemotherapy
  • Breast cancer diagnosis
  • Pregnant women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661242


Contacts
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Contact: Agnes Smaradottir, MD + 354 5431000 agnessma@landspitali.is
Contact: Halla Arnardottir, RN +354 5435711 hallarn@landspitali.is

Locations
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United States, Wisconsin
Gundersen Health System Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Kurt Oettle, MD    608-782-7300      
Contact: Amee Vang, MPH    608-775-7816    cavang@gundersenhealth.org   
Iceland
Landspitali - The National University Hospital of Iceland Recruiting
Reykjavik, Iceland, 101
Contact: Halla Arnardottir    +354-543-1000    hallarn@lsh.is   
Contact: Eyrun Steinsson    +354-543-1000 ext 1465    eyrunst@lsh.is   
Sub-Investigator: Runolfur Palsson, MD         
Sponsors and Collaborators
Landspitali University Hospital
Gundersen Health System
Investigators
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Principal Investigator: Agnes Smaradottir, MD Landspitali University Hospital
More Information
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Responsible Party: Landspitali University Hospital
ClinicalTrials.gov Identifier: NCT03661242    
Other Study ID Numbers: LSH-18-001
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Landspitali University Hospital:
Physical activity
Exercise
Adjuvant chemotherapy